MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEC SET NO PORTS W/HANGER DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 11448964

Device Problem Fluid/Blood Leak (1250)

Patient Problem Chemical Exposure (2570)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 11448964 because a valid lot number was not provided by the customer.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: the root cause of this failure could not be identified without a failure investigation.

Event Description

It was reported that sec set no ports w/hanger dehp free disconnected.The following information was provided by the initial reporter: chemical exposure and fluid leak.

• Brand Name: SEC SET NO PORTS W/HANGER DEHP FREE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• MDR Report Key: 12330522
• MDR Text Key: 266848260
• Report Number: 9616066-2021-51807
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403234743
• UDI-Public: 10885403234743
• Combination Product (y/n): N
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 11448964
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other